omnipaque

Generic: iohexol

Labeler: ge healthcare
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name omnipaque
Generic Name iohexol
Labeler ge healthcare
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

iohexol 300 mg/mL

Manufacturer
GE Healthcare

Identifiers & Regulatory

Product NDC 0407-1413
Product ID 0407-1413_ada60f08-6a13-438b-a0ae-8378bc8f1998
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020608
Listing Expiration 2026-12-31
Marketing Start 2016-12-21

Pharmacologic Class

Established (EPC)
radiographic contrast agent [epc]
Mechanism of Action
x-ray contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04071413
Hyphenated Format 0407-1413

Supplemental Identifiers

UNII
4419T9MX03
NUI
N0000180185 N0000010258

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name omnipaque (source: ndc)
Generic Name iohexol (source: ndc)
Application Number NDA020608 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/mL
source: ndc
Packaging
  • 10 BOTTLE, PLASTIC in 1 BOX (0407-1413-72) / 500 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0407-1413-72 10 BOTTLE, PLASTIC in 1 BOX (0407-1413-72) / 500 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

iohexol (300 mg/mL)

Linked Drug Pages (2)

Omnipaque ndc-match (0.9) OMNIPAQUE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ada60f08-6a13-438b-a0ae-8378bc8f1998", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["4419T9MX03"], "spl_set_id": ["164b27b9-97ae-4279-896f-1c4afa583dd1"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["GE Healthcare"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-1413-72)  / 500 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-1413-72", "marketing_start_date": "20161221"}], "brand_name": "Omnipaque", "product_id": "0407-1413_ada60f08-6a13-438b-a0ae-8378bc8f1998", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0407-1413", "generic_name": "Iohexol", "labeler_name": "GE Healthcare", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omnipaque", "active_ingredients": [{"name": "IOHEXOL", "strength": "300 mg/mL"}], "application_number": "NDA020608", "marketing_category": "NDA", "marketing_start_date": "20161221", "listing_expiration_date": "20261231"}